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•Mediwest Specialty Distribution LLC•December 20, 2022

FDA 483 - Mediwest Specialty Distribution LLC - December 20, 2022

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Record Details

An FDA inspection of Mediwest Specialty Distribution LLC in Hormigueros, PR, an HT Warehouse, revealed significant deficiencies in their operations. The firm failed to establish and implement critical procedures for the storage, handling, distribution, and complaint management of human tissue products. These failures indicate a lack of adherence to good tissue practices.

Company
Mediwest Specialty Distribution LLC
Inspection Date
December 20, 2022
Product Type
Biologics
Office
Division of Human and Animal Food Operations - East IV
Person
  • Laura E. Garcia
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ID · 932c5a0e-2539-48a5-ba6a-c377d9048e57

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